BEUDAMED
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    HAMILTON-C1

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·August 30, 2024

    HAMILTON-T1, HAMILTON-C1

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Chord-X Premeasured Loops and Suture System

    FDA UDI
    ON-X LIFE TECHNOLOGIES, INC.·00813570020329·Artificial chordal replacement prosthesis

    Chord-X Premeasured Loops and Suture System

    FDA UDI
    ON-X LIFE TECHNOLOGIES, INC.·00813570020220·Artificial chordal replacement prosthesis

    OSSEOTITE 2 DENTAL IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    AUDIT MICROCV PROTEIN LINEARITY SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NEEDLE 21GA 2IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·January 8, 2020

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 21, 2013

    HUDSON REUSABLE MANUAL RESUSCITATION BAG/MASK

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BTM·July 7, 2011

    SOLETRA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·September 30, 2008

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014